To Design QBD (Quality-by-Design) Approach to Understand the Processing Factors Impact Melt-Extruded Solid Dispersions with an Instantaneous Release

Abstract

Quality by Design (QbD) is a method for determining which patient-reported quality factors are most important, translating those factors into product attributes, and then determining how to consistently produce drug products with those attributes by varying key process parameters. For this purpose, it is necessary to identify sources of variability and create correlations between product features and factors pertaining to the formulation and manufacturing process, such as the properties of the medication ingredient and excipients, as well as process parameters. Using this information, a strong and adaptable manufacturing process is put into place, allowing it to consistently create high-quality products over time. Although hot-melt extrusion (HME) has been around for a while in the food and plastics industries, it wasn't until 1971 when El-Egakey et al. used it to pharmaceutical formulation. Different research organizations dug further into this method, honing it for use in the pharmaceutical industry.
Keywords: Quality by Design (QbD), pharmaceutical, organizations, extrusion, method.